Evaluation of Semi-rigid and Flexible Catheters for Less Invasive Surfactant Administration in Preterm Infants With Respiratory Distress Syndrome - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Successful intratracheal tube Placement
研究概览
简要总结
The overall aim of this study is to determine the differences between two surfactant administration catheters in preterm infants.
详细描述
In this single-center, open-label, randomized-controlled trial, preterm infants requiring surfactant administration after birth, using a standardized minimal invasive protocol, were randomised to two different modes of endotracheal catheterization: Flexible Ch-4 feeding tube inserted using Magill forceps (group 1) and semi-rigid catheter (group 2). Primary outcome was duration of laryngoscopy. Secondary outcomes were complication rate and vital parameters during laryngoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants born less than 37 weeks of gestation
- •Treating physician in charge of admission decides to administer intratracheal surfactant via standardized institution- LISA protocol (regardless of this study) (see Supplement file 1)
- •Written informed consent signed by caregivers or legal representative to participate
排除标准
- •Refusal to participate in study or not providing written informed consent by caregivers/parents
- •Treating physician decides to use different route of surfactant administration or does not adhere to LISA protocol.
- •Rupture of membranes (ROM) at less than 22 weeks of gestation or more than 6 weeks before birth
- •Estimated birth weight < 3rd percentile using 2013 Fenton growth trajectories
- •Twins with feto-fetal transfusion syndrome (FFTS) and FFTS being the cause of premature delivery
- •Contraindications listed in the LISAcath® or Nasogastric Tube manual (esophageal/pharyngeal varices or other vascular lesions, esophageal/pharyngeal tumor, nasal fracture, skull fracture, known allergy to material)
结局指标
主要结局
Successful intratracheal tube Placement
时间窗: Birth to 24 hours after birth
次要结局
未报告次要终点
研究者
Lorenz Auer-Hackenberg
Medical Doctor, University Hospital Salzburg, Department of Pediatrics and Adolescent Medicine, Physician Division of Neonatology
Salzburger Landeskliniken